Course code
FD132
Duration
8 hours

This course provides learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry and in the context of the requirements of ISO 13485.

This is compatible with IMDRF members’ medical device regulators, individual country standards and provides a basis for learners who wish to go on to complete CQI and IRCA Certified MD-QMS Auditor Training courses.

Who is it for?

This course is for those requiring an introduction to ISO 13485, especially those involved in the design, implementation and management of an MD-QMS.

Learning outcomes

1. Explain the purpose of a medical device quality management system.

2. Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF.

3. Explain the specific quality management-related requirements of ISO 13485.

Recommended prior knowledge

Management systems

  • The Plan, Do, Check, Act (PDCA) cycle.

  • The core elements of a management system and the interrelationship between scope, top management commitment, policy, planning, objectives, performance evaluation, measurement, review, and continual improvement.

Quality management

  • The fundamental concepts and the seven quality management principles (see ISO 9000).

  • The relationship between quality management, regulatory compliance and satisfying customer requirements.

Quality management terms and definitions

  • The commonly used quality management terms and definitions (see ISO 13485 and ISO 9000).

Assessment 

Learners must demonstrate achievement of the learning and enabling objectives in accordance with the ATP’s defined learning evaluation methods and the CQI’s assessment requirements.